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Difference in Grades of Epiblepharon According to Positional Changes and General Anesthesia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Yonsei University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650688
First Posted: July 26, 2012
Last Update Posted: July 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose

Epiblepharon is a very common condition among Asian children and is a fold of the skin and underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the lashes against the cornea. It is manifested by the anterior lamella overriding the posterior lamella which causes the lashes to brush against the cornea. Although the prevalence of epiblepharon is known to be high among Asians, its cause remains controversial. Several etiological factors may be involved in the pathogenesis of epiblepharon.

Although epiblepharon in the lower lids lessens and disappears with age in many cases, surgery must be performed at an early age in severe cases in order to prevent ocular trauma as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced keratitis and astigmatism are indications for surgical intervention.

Over our many years of surgical experience, the investigators came to realize that the severity of epiblepharon was reduced when patients were under general anesthesia during surgery. The purpose of this study was to investigate the role of the orbicularis muscle in the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of epiblepharon in the upright versus the supine position and before and after the induction of general anesthesia.


Condition
Epiblepharon

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Degree of skin fold height [ Time Frame: 1 hour before epiblepharon surgery ]

Estimated Enrollment: 63
Study Start Date: July 2012
Estimated Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epiblepharon
subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with epiblepharon which needed surgical correction
Criteria

Inclusion Criteria:

  • subjects younger than 12 years
  • more than 12 months' follow-up
  • subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms
  • subjects who underwent general anesthesia for surgical correction of epiblepharon

Exclusion Criteria:

  • subjects older than 12 years
  • less than 12 months' follow-up -. subjects who underwent surgery on local anesthesia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650688


Locations
Korea, Republic of
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01650688     History of Changes
Other Study ID Numbers: 4-2012-0315
First Submitted: July 15, 2012
First Posted: July 26, 2012
Last Update Posted: July 26, 2012
Last Verified: July 2012

Keywords provided by Yonsei University:
Epiblepharon, general anesthesia, positional change